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About
Good Clinical Practice (GCP) for Medical Devices ISO 14155:2026 is a comprehensive program designed to provide professionals with the knowledge and skills required to plan, conduct, monitor, and oversee medical device clinical investigations in accordance with international Good Clinical Practice standards. The course is aligned with ISO 14155:2026 and focuses on protecting study participants, ensuring data integrity, and maintaining regulatory compliance throughout the clinical investigation lifecycle.
This Good Clinical Practice (GCP) for Medical Devices ISO 14155:2026 Course & Certification provides practical training in ethical principles, informed consent, clinical investigation planning, risk management, safety reporting, data management, quality oversight, audits, inspections, and study close-out activities. Participants gain a thorough understanding of sponsor and investigator responsibilities, governance requirements, and best practices for conducting compliant clinical investigations. Upon completion, learners receive certification demonstrating competency in medical device GCP principles and ISO 14155:2026 requirements.
- Clinical Research, Clinical Affairs, and Clinical Operations Professionals involved in medical device studies.
- Medical Device Regulatory Affairs, Quality Assurance, and Compliance Personnel.
- Investigators, Clinical Research Coordinators, Study Monitors, and Sponsor Representatives.
- Medical Device Manufacturers, Clinical Project Managers, and Risk Management Professionals.
- Entry-level professionals and consultants seeking ISO 14155:2026 certification and expertise in medical device clinical investigations and GCP compliance.
What you will learn
Understand ISO 14155:2026 requirements, GCP principles, ethical considerations, participant protection, and informed consent processes in medical device clinical investigations.
Learn how to plan, conduct, manage, and oversee clinical investigations, including roles and responsibilities of sponsors, investigators, and study personnel.
Develop expertise in risk management, data management, documentation practices, safety reporting, and maintaining data integrity throughout the study lifecycle.
Gain knowledge of audits, inspections, quality oversight, governance requirements, study suspension, termination, close-out procedures, and regulatory compliance expectations.
Course Syllabus
- What is ISO 14155?
- History & Evolution of ISO 14155
- What's New in ISO 14155:2026?
- Scope and Application
- Key Terms & Definitions — Part 1
- Key Terms & Definitions — Part 2
- The 14 Principles of Good Clinical Practice
- GCP Principles in Practice
- Ethical Foundations
- Ethics Committee Review
- Vulnerable Populations
- Informed Consent — Overview
- Electronic Consent (eConsent)
- Clinical Investigation Planning Framework
- The Clinical Investigation Plan (CIP)
- Study Types & Designs
- The Estimand Framework — Annex K
- Risk Management Overview
- Device Risks vs. Procedural Risks
- Sponsor Responsibilities
- Principal Investigator (PI) Responsibilities
- CRO Oversight & Delegation
- ALCOA++ Data Integrity Principles
- Trial Master File (TMF)
- Electronic Data Capture (EDC)
- Adverse Event Categorisation
- Safety Reporting Timelines
- Proportionate Safety Reporting
- Quality by Design (QbD) in Clinical Investigations
- Risk-Based Monitoring (RBM)
- Preparing for Regulatory Inspections
- Common Audit & Inspection Findings
- Study Suspension & Early Termination
- Study Close-out Activities
- Clinical Events Committees (CECs)
- Data Monitoring Committees (DMCs)
- Governance Decision Logic
- Step 1: Run a Formal Gap Analysis
- Step 2: Update QMS & SOPs
- Steps 3 & 4: Training and Ongoing Studies
- ISO 14155:2026 Annexes — Overview
- Annex K: Estimands — Deep Dive
- Annex H: Risk Management — Deep Dive
- Global Regulatory Alignment
- Drug-Device Combination Products
- The Clinical Investigation Lifecycle
- Key Takeaways from ISO 14155:2026
- ISO 14155:2020 vs. ISO 14155:2026 — At a Glance
- Glossary of Key Abbreviations
- Resources & Further Reading
- Course Summary
- Assessment & Certification
Our Certified Customers
Learner Rating & Reviews
Frequently Asked Questions
- Core principles of ISO 14155:2026 and Good Clinical Practice for medical device investigations
- Clinical investigation lifecycle including planning, conduct, and close-out
- Development and application of Clinical Investigation Plans (CIP)
- Continuous risk management integrated with ISO 14971
- Safety reporting requirements (AE, SAE, USADE) and reporting timelines
- Data integrity principles including ALCOA++ and TMF management
- Governance structures including CECs and DMCs
- Modern approaches such as eConsent and risk-based monitoring
This course is ideal for professionals involved in medical device clinical investigations, including:
- Clinical Affairs and Regulatory Affairs professionals
- Quality Assurance and compliance teams
- Principal Investigators and clinical site staff
- CRO professionals and clinical project managers
- Anyone seeking to understand ISO 14155:2026 requirements and GCP for medical devices
- Comprehensive training aligned with ISO 14155:2026 international standard
- Updated with latest regulatory expectations including ICH GCP E6(R3), EU MDR/IVDR, and FDA guidelines
- Practical guidance on risk management, safety reporting, and audit readiness
- Covers new 2026 updates including Annex K estimands and governance frameworks
- Enhances understanding of data integrity and inspection preparedness
- Certificate issued upon successful completion








